Dengue Vaccine in Phase 3 Clinical Trial

Sanofi Pasteur, the vaccines division of the French pharmaceutical company Sanofi-Aventis, says that its dengue vaccine is in the final stage of clinical development — its first phase 3 clinical study in Australia. Phase 3 trials involve large groups of patients to confirm a drug’s effectiveness, monitor side effects, and compare it to commonly used treatments.

This study in Australia is part of a global phase 3 clinical study to help develop a vaccine for the prevention of the disease in children and adults. Currently, there is no specific treatment available for dengue fever, a mosquito-borne disease that threatens more than one-third of the world’s population, and a public health priority in many countries of Latin America and Asia where epidemics occur.

Sanofi Pasteur says its candidate dengue vaccine — which targets all four virus serotypes — has been evaluated in Phase 1 and 2 clinical studies in adults and children in the U.S., Asia, and Latin America. The trials so far show a balanced immune response against all four serotypes after three doses of the vaccine.

The study in Australia is the first to use dengue vaccine doses produced with industrial scale processes. The study is aimed at demonstrating that production of the vaccine at industrial scale will meet consistency criteria required by regulatory authorities for general distribution.

Photo: Germán Meyer/Flickr

*     *     *